NCT01360151

Brief Summary

This is a prospective, comparative control analysis. The investigators want to evaluate the aqueous humor levels of vascular endothelial growth factor in polypoidal choroidal vasculopathy and the effect of photodynamic therapy and combination treatment of photodynamic therapy and Lucentis (Ranibizumab)on the level of vascular endothelial growth factor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2011

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
Last Updated

May 30, 2011

Status Verified

April 1, 2011

Enrollment Period

3 months

First QC Date

April 12, 2011

Last Update Submit

May 27, 2011

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

VEGF (Vascular endothelial growth factor)

Outcome Measures

Primary Outcomes (1)

  • change from baseline in cytokine levels at 1 week, 1 month and 3 month

    1. To compare the baseline level of cytokines in aqueous humor. polypoidal choroidal vasculopathy group(Arm A+Arm B) vs normal control group 2. To compare the change of cytokine level of aqueous humor after combination treatment of intravitreal injection of Lucentis™ and photodynamic therapy versus only photodynamic therapy.(1 week, 1 month, 3 month)

    baseline, 1 week, 1 month, 3 month

Study Arms (3)

experimental

EXPERIMENTAL

Arm 1 : combination treatment of ranibizumab(Lucentis) and verteporfin(Visudyne) injection

Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

active comparator

ACTIVE COMPARATOR

Arm 2 : Treatment of verteporfin(Visudyne)

Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

normal control group

NO INTERVENTION

Arm 3 : normal control group

Drug: ranibizumab(Lucentis), verteporfin(Visudyne)

Interventions

ranibizumab(Lucentis), verteporfin(Visudyne)DRUG

ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection

Also known as: ranibizumab(Lucentis) : 0.5mg/0.05ml, verteportin (Visudyne) : 15mg (6mg/m2)
active comparatorexperimentalnormal control group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female patients ≥ 45yrs of age
  • Best corrected Visual acuity 20/30 to 20/320 Snellen equivalent using ETDRS chart measured at 4 meters
  • Signed written informed consent
  • Evidence of Polypoidal choroidal vasculopathy , active in disease activity.
  • Presence of subfoveal, juxtafoveal or extrafoveal active characteristic macular polypoidal lesions on indocyanine green angiography
  • Confirmed to be active in disease activity by fluorescein angiography
  • The total lesion must have the greatest linear dimension less than 5400 microns ( \~9 MPS Disc Areas ) as delineated by indocyanine green angiography
  • Had not been treated in the past
  • Patients willing and able to comply with all study procedures

You may not qualify if:

  • Previous history of laser photocoagulation,photodynamic therapy,anti VEGF therapy, submacular surgery in the study eye
  • Have known hypersensitivity to Visudyne® and Lucentis™
  • Previous treatment with external-beam radiation therapy or transpupillary thermotherapy
  • History of vitrectomy
  • Intraocular surgery,yttrium aluminum garnet(YAG) laser\< 1month before day 0
  • Additional eye disease that could compromise visual acuity
  • Ocular inflammation
  • Vitreous hemorrhage
  • Uncontrolled glaucoma
  • Current use or of likely need for systemic medications known to be toxic to the eye.
  • Inability to obtain fluorescein angiography and indocyanine green angiography, due to media opacity, allergy to the dye or lack of venous access
  • Are participating in another clinical study.
  • Disciform scar
  • Mental illness that precludes the patient from giving informed consent
  • Patients who are considered potentially unreliable
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Won Ki Lee

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PorphyrinsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2011

First Posted

May 25, 2011

Study Start

February 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 30, 2011

Record last verified: 2011-04

Locations

KR(1)